MFDS Designates Software as Innovative Medical Device to Aid Diagnosis of Retinal Diseases

The Ministry of Food and Drug Safety announced on the 24th that the ophthalmic imaging detection and diagnostic support software "WISKY," which helps medical professionals diagnose retinal diseases, has been designated as the 40th innovative medical device.

Whiskey Products

WISKY is the first domestic product that simultaneously analyzes three retinal diseases (macular degeneration, glaucoma, diabetic retinopathy) that can lead to blindness by analyzing fundus images using artificial intelligence (AI) technology.

The Ministry explained that it was designated as an innovative medical device due to its "technological innovation" and the "market creation potential" in response to the increasing trend of retinal disease patients.

WISKY is already a product approved by the Ministry of Food and Drug Safety and has completed integrated review and evaluation. Integrated review and evaluation refers to the simultaneous process conducted by the Ministry and related agencies for innovative medical device designation, confirmation of insurance coverage eligibility, and innovative medical technology evaluation. This process reduces the duration from up to 390 days to 80 days, allowing medical devices to quickly enter the medical field.

WISKY is expected to enter the medical field immediately as a non-reimbursed service after the revision and promulgation (on the 30th) of the "Safety and Effectiveness Evaluation Results of New Medical Technologies" by the New Medical Technology Evaluation Committee, and will be used for 3 to 5 years.

This content was produced with the assistance of AI translation services.